Treating inflamed hearts with cells may lead to broader health benefits
“This cell therapy uniquely targets inflammation as a core mechanism of the disease and is designed to be an additive treatment option to what are already the best evidence-based heart failure medicines available to patients. I am extremely encouraged by these clinical findings that extend the benefits of cells to preventing heart attack and stroke in addition to having local benefits in the heart.” – Emerson C. Perin, MD, PhD, Principal Investigator, DREAM-HF Trial
Cell therapy reduces risk of heart attack and stroke in heart failure patients with underlying inflammation – A late-breaking clinical trial (DREAM-HF: Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells for the Treatment of Heart Failure) was presented by Emerson C. Perin, MD, PhD at the American Heart Association 2021 Scientific Sessions. DREAM-HF is the single largest trial of cell-based therapy for heart failure, with 565 patients enrolled across 51 sites throughout the US and Canada with a mean follow-up of 30 months.
In heart failure patients on the best guideline-directed medical therapy, treatment with cells injected directly into their hearts proved to have local and systemic benefits. The study demonstrated reductions in heart attack and stroke of up to 80% in patients with high levels of inflammation. A pivotal phase III trial based on these findings is currently being planned and could shepherd in a new era in treatment strategies for heart failure patients.
Cell therapies in ongoing trials at THI include treatments for drug-induced cardiomyopathy in cancer patients and for non-ischemic dilated cardiomyopathy.
Also in 2021, CONCERT-HF (Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure) trial results were published in the European Journal of Heart Failure and showed that directly injecting two different types of stem cells into the heart could reduce the risk of major cardiac adverse events and improve patients’ quality of life. This study concluded THI’s 12-year participation in the NIH-funded Cardiovascular Cell Therapy Research Network (CCTRN).
Continued Leadership in Stem Cell Clinical Trials
In conjunction with The University of Texas MD Anderson Cancer Center, the CCR is participating in a trial funded by the Texas Medical Center titled “Trial With MSCs vs Standard of Care in Cardiomyopathy: Randomized 3-Arm Trial with Standard of Care Alone vs Either Intravenous Infusion or Transendocardial Injection of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) plus Standard of Care in Patients with Anthracycline-Associated Cardiomyopathy.” This study is evaluating the safety of adding mesenchymal stem cells (MSCs) to standard-of-care drugs for patients with heart failure caused by anthracyclines (a type of chemotherapy drug). The stem cells are derived from the bone marrow of healthy donors. Patients receive MSCs injected into the heart through a catheter or in an IV.
CCR also is participating in a study funded by the US Department of Defense and sponsored by the University of Miami: A Phase IIB Randomized, Placebo-Controlled, Multicenter Study of the Comparative Efficacy and Safety of Transendocardial Injection of Allogeneic-MSC Versus Placebo in Patients with Non-Ischemic Dilated Cardiomyopathy (DCM II). The purpose of the DCM II trial is to determine whether giving allogeneic human mesenchymal stem cells (hMSCs) transendocardially to patients with nonischemic dilated cardiomyopathy (NIDCM) is safe and whether treatment with hMSCs produces greater improvement in heart function in some patients than in others because of their genetics. CCR is working closely with the Department of Stem Cell Transplantation and Cellular Therapy at MD Anderson Cancer Center, which is handling the processing of the stem cells for the research patients at THI.